Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, The Netherlands; GROW School for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.
Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, The Netherlands.
Am J Obstet Gynecol. 2024 May;230(5):542.e1-542.e10. doi: 10.1016/j.ajog.2024.01.016. Epub 2024 Jan 26.
The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers.
This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation.
This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction.
From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction.
The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.
月经过多的症状对专业、身体和社交功能有重大影响。2021 年，一项比较 52mg 左炔诺孕酮释放宫内节育系统和射频非切除性子宫内膜消融作为治疗月经过多妇女的随机对照试验结果公布。两种治疗策略在 2 年随访期间治疗月经过多同样有效。然而，长期结果对患者和医疗保健提供者也同样重要。
本研究旨在评估根据 52mg 左炔诺孕酮释放宫内节育系统或射频非切除性子宫内膜消融策略治疗的月经过多症状妇女的再次干预风险和月经失血量的长期差异。
这是一项多中心随机对照试验（MIRA 试验）的长期随访研究，将妇女随机分配至 52mg 左炔诺孕酮释放宫内节育器（n=132）或射频非切除性子宫内膜消融（n=138）组。联系原始试验中的女性填写 6 份问卷。主要结局是分配治疗后的再干预率。次要结局包括手术再干预率、经 Pictorial Blood Loss Assessment Chart 测量的月经出血量（疾病特异性）生活质量、性功能和患者满意度。
在原始试验中随机分配的 270 名女性中，196 名（52mg 左炔诺孕酮释放宫内节育器组：n=94；射频非切除性子宫内膜消融组：n=102）参加了这项长期随访研究。平均随访时间为 7.4 年（范围 6-9 年）。52mg 左炔诺孕酮释放宫内节育器组的累积再干预率（包括医疗和手术再干预）为 40.0%（34/85），射频非切除性子宫内膜消融组为 28.7%（27/94）（相对风险 1.39；95%置信区间 0.92-2.10）。与射频非切除性子宫内膜消融相比，起始治疗策略为 52mg 左炔诺孕酮释放宫内节育器的患者的手术再干预率显著更高（35.3%[30/85] vs 19.1%[18/94]；相对风险 1.84；95%置信区间 1.11-3.10）。然而，子宫切除术率相似（52mg 左炔诺孕酮释放宫内节育器组 11.8%[10/94]，射频非切除性子宫内膜消融组 18.1%[17/94]；相对风险 0.65；95%置信区间 0.32-1.34）。大多数再干预发生在随访的前 24 个月。共 171 个 Pictorial Blood Loss Assessment Chart 评分中位数出血评分均为 0.0。在生活质量、性功能和患者满意度方面未发现有临床意义的差异。
长期随访后，根据起始治疗策略为 52mg 左炔诺孕酮释放宫内节育器和起始治疗策略为射频非切除性子宫内膜消融的妇女再次干预的总体风险无差异。然而，起始治疗策略为 52mg 左炔诺孕酮释放宫内节育器的妇女手术再干预风险更高，这是由于随后子宫内膜消融的增加所致。两种治疗策略均能长期有效降低月经出血量。这项长期随访研究的结果可以为医生提供支持，从而优化对月经过多妇女的咨询，促进治疗选择的知情决策。
